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The purpose of this study was to determine the safety and effectiveness of different doses of botulinum toxin Type A in treating lower urinary tract symptoms due to benign prostatic hyperplasia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| botulinum toxin Type A 300 U | Experimental | Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1. |
|
| botulinum toxin Type A 200 U | Experimental | Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1. |
|
| botulinum toxin Type A 100 U | Experimental | Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1. |
|
| Placebo (Normal Saline) | Placebo Comparator | Placebo (Normal Saline) transperineal or transrectal injection on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| botulinum toxin Type A | Biological | Botulinum toxin Type A 300 U, 200 U or 100 U transperineal or transrectal injection on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12 | The International Prostate Symptom Score is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72 | The International Prostate Symptom Score is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain | The IIEF is a 15-item questionnaire filled out by the patient to assess erectile function over the past 4 weeks that contains five domains. The score for the erectile function domain is the sum of scores for Questions 1, 2, 3, 4, 5 and 15 for a total possible score of 1 to 30. A higher score indicates a better outcome. A positive change from baseline indicates improvement. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Murdoch | Australia | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23098762 | Derived | Marberger M, Chartier-Kastler E, Egerdie B, Lee KS, Grosse J, Bugarin D, Zhou J, Patel A, Haag-Molkenteller C. A randomized double-blind placebo-controlled phase 2 dose-ranging study of onabotulinumtoxinA in men with benign prostatic hyperplasia. Eur Urol. 2013 Mar;63(3):496-503. doi: 10.1016/j.eururo.2012.10.005. Epub 2012 Oct 12. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Botulinum Toxin Type A 300 U | Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1. |
| FG001 | Botulinum Toxin Type A 200 U | Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| normal saline | Drug | Normal Saline (Placebo) transperineal or transrectal injection on Day 1. |
|
| Baseline, Week 72 |
| Change From Baseline in Peak Urine Flow Rate | Urinary flow was determined by uroflowmetry at baseline and various time-points during the study. An increase from baseline indicates improvement. | Baseline, Week 12, Week 72 |
| Change From Baseline in Total Prostate Volume | Measurement of the prostate volume was performed via transrectal ultrasound at baseline and various time-points during the study. The prostate gland was scanned and the volume was calculated using the formula: Volume (mL) = length × width × height × 0.523. A negative change from baseline indicates improvement. | Baseline, Week 12, Week 72 |
| Change From Baseline in Transitional Zone Prostate Volume | Measurement of the transitional zone prostate volume was performed via transrectal ultrasound at baseline and various time-points during the study. The prostate gland was scanned and the volume was calculated using the formula: Volume (mL) = length × width × height × 0.523. A negative change from baseline indicates improvement. | Baseline, Week 12, Week 72 |
| Change From Baseline in Post-Void Residual | Post-void residual urine volume was assessed by bladder scan or ultrasound on all participants at baseline and various time-points during the study. After voiding, any residual urine volume in the bladder was measured. A negative change from baseline indicates improvement. | Baseline, Week 2, Week 12, Week 72 |
| Baseline, Week 12, Week 72 |
| Vienna |
| Austria |
| Victoria | British Columbia | Canada |
| Olomouc | Czechia |
| Paris | France |
| Braunschweig | Germany |
| Perugia | Italy |
| Martin | Slovakia |
| Seoul | South Korea |
| Taipei | Taiwan |
| London | United Kingdom |
| FG002 | Botulinum Toxin Type A 100 U | Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1. |
| FG003 | Placebo (Normal Saline) | Placebo (Normal Saline) transperineal or transrectal injection on Day 1. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Botulinum Toxin Type A 300 U | Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1. |
| BG001 | Botulinum Toxin Type A 200 U | Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1. |
| BG002 | Botulinum Toxin Type A 100 U | Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1. |
| BG003 | Placebo (Normal Saline) | Placebo (Normal Saline) transperineal or transrectal injection on Day 1. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12 | The International Prostate Symptom Score is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement. | Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 12 |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72 | The International Prostate Symptom Score is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement. | Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 72 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Peak Urine Flow Rate | Urinary flow was determined by uroflowmetry at baseline and various time-points during the study. An increase from baseline indicates improvement. | Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point. | Posted | Mean | Standard Deviation | milliliters (mL)/second | Baseline, Week 12, Week 72 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total Prostate Volume | Measurement of the prostate volume was performed via transrectal ultrasound at baseline and various time-points during the study. The prostate gland was scanned and the volume was calculated using the formula: Volume (mL) = length × width × height × 0.523. A negative change from baseline indicates improvement. | Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point. | Posted | Mean | Standard Deviation | milliliter (mL) | Baseline, Week 12, Week 72 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Transitional Zone Prostate Volume | Measurement of the transitional zone prostate volume was performed via transrectal ultrasound at baseline and various time-points during the study. The prostate gland was scanned and the volume was calculated using the formula: Volume (mL) = length × width × height × 0.523. A negative change from baseline indicates improvement. | Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point. | Posted | Mean | Standard Deviation | milliliters (mL) | Baseline, Week 12, Week 72 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Post-Void Residual | Post-void residual urine volume was assessed by bladder scan or ultrasound on all participants at baseline and various time-points during the study. After voiding, any residual urine volume in the bladder was measured. A negative change from baseline indicates improvement. | Participants from the safety population (includes all randomized and treated participants) with data available for analyses at the given time-point. | Posted | Mean | Standard Deviation | milliliters (mL) | Baseline, Week 2, Week 12, Week 72 |
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain | The IIEF is a 15-item questionnaire filled out by the patient to assess erectile function over the past 4 weeks that contains five domains. The score for the erectile function domain is the sum of scores for Questions 1, 2, 3, 4, 5 and 15 for a total possible score of 1 to 30. A higher score indicates a better outcome. A positive change from baseline indicates improvement. | Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 12, Week 72 |
| ||||||||||||||||||||||||||||||||||||
| Post-Hoc | Change From Baseline in IPSS at Week 12 in Patients Previously Treated With Alpha-blockers | The International Prostate Symptom Score (IPSS) is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement. | Participants from the Intent-to-treat population previously treated with alpha-blockers with data available for analyses. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 12 |
|
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Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Botulinum Toxin Type A 300 U | Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1. | 9 | 94 | 41 | 94 | ||
| EG001 | Botulinum Toxin Type A 200 U | Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1. | 16 | 93 | 46 | 93 | ||
| EG002 | Botulinum Toxin Type A 100 U | Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1. | 10 | 94 | 53 | 94 | ||
| EG003 | Placebo (Normal Saline) | Placebo (Normal Saline) transperineal or transrectal injection on Day 1. | 11 | 92 | 55 | 92 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Blindness unilateral | Eye disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Retinal artery thrombosis | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Corneal degeneration | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Accidental death | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Bacterial prostatitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Prostatic specific antigen increased | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Gastric adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Alcoholism | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Calculus bladder | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Prostatic specific antigen increase | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Renal cyst | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Haematospermia | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| >65 Years |
|
| Male |
|
| Change from baseline at Week 12 (N=86,89,93,90) |
|
| OG003 | Placebo (Normal Saline) | Placebo (Normal Saline) transperineal or transrectal injection on Day 1. |
|
|
|
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Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
|
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Placebo (Normal Saline) transperineal or transrectal injection on Day 1. |
|
|
Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
|
|
| Placebo (Normal Saline) |
Placebo (Normal Saline) transperineal or transrectal injection on Day 1. |
|
|
| OG003 | Placebo (Normal Saline) | Placebo (Normal Saline) transperineal or transrectal injection on Day 1. |
|
|